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A Clinical Study Comparing Standard Anastomosis Closure Technique to Standard Closure Techniques Plus Sylys® Surgical Sealant

NCT02841891 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2018-08-16

No results posted yet for this study

Summary

The Cohera Sylys® Surgical Sealant study is a prospective, randomized, controlled, multicenter clinical study comparing standard anastomosis closure technique (Control) to standard closure technique plus Sylys® Surgical Sealant (Test) in patients undergoing a colectomy procedure with a stapled anastomosis.

Conditions

  • Colorectal and Ileorectal Anastomosis
  • Colocolic and Ileocolic Anastomosis
  • Coloanal and Ileoanal Anastomosis

Interventions

DEVICE

Sylys® Surgical Sealant

Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant

PROCEDURE

Stapled Anastomosis Colectomy Procedure

Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant

Sponsors & Collaborators

  • Cohera Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-08-13
Completion
2018-08-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02841891 on ClinicalTrials.gov